A PET Study of the Effects of p38 MAP Kinase Inhibitor, VX-745, on Amyloid Plaque Load in Alzheimer's Disease (AD)

EIP Pharma

Status and phase

Completed

Phase 2

Conditions

Alzheimer's Disease

Mild Cognitive Impairment

Treatments

Drug: VX-745

Study type

Interventional

Funder types

Industry

Identifiers

NCT02423122

EIP-VX00-745-302

Details and patient eligibility

About

This study will assess the effects of administration of VX-745 for 12 weeks on amyloid plaque burden in Alzheimer's disease (AD). Subjects who meet entry criteria will undergo 11C-PiB (Carbon-11-labeled Pittsburgh Compound B) positron emission tomography (PET) at baseline and after 45 days of dosing with VX-745. Cognitive testing will also be conducted at baseline and day 45.

Enrollment

16 patients

Sex

All

Ages

60 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Willing and able to provide informed consent
Diagnosis of mild cognitive impairment (MCI) due to probable AD or of mild AD
MMSE range: 20 to 28
Evidence of amyloid pathology by amyloid PET scan
Participants may be taking medications for AD, provided that the dose of these medications has been stable for >3 months
Proficiency in Dutch and adequate visual and auditory abilities to be able to perform all aspects of the cognitive and functional tests
Adequate visual and auditory abilities to perform all aspects of the cognitive and functional assessments.

Exclusion criteria

Evidence of neurodegenerative disease other than AD
Inability for any reason to undergo PET and fMRI scans (including notably: history of allergic reaction of any severity to 11C-PiB injection; pacemaker, vascular stent or stent graft)
Psychiatric disorder that would compromise ability to comply with study requirements
Significant cardiovascular, pulmonary, renal, liver, infectious disease, immune disorder or metabolic/endocrine disorders or other disease that would preclude treatment with p38 MAP kinase inhibitor and/or assessment of drug safety and efficacy
Recent (<90 days) changes to AD medications prescribed for cognitive reasons or with the potential to impact cognition
Participation in a study of an investigational drug less than 6 months or 5 half-lives of the investigational drug, whichever is longer, before enrollment in the study
Male subjects with female partner of child-bearing potential who are unwilling or unable to adhere to contraception requirements
Female subjects who have not reached menopause or have not had a hysterectomy or bilateral oophorectomy/salpingoophorectomy
Positive urine or serum pregnancy test or plans desires to become pregnant during the course of the trial
Any factor deemed by the investigator to be likely to interfere with study conduction